The study protocol provides the investigator and study staff with detailed instructions on how to conduct the study. The protocol discusses who can be in the study, the length of the study, how much of the drug study participants might receive, how often the drug is given, the type of test or procedures that will be done during the study. The study protocol will let study participants know how often they will visit the research center. An informed consent is given to study participants for their review. The informed consent provides each study participant with an explanation of the purposes of the research. It also includes a description of the procedures being used in the study, a description of foreseeable risks or discomfort to the study participant. The informed consent also contains a statement of alternative treatments available to the study participant along with a statement of confidentiality. There is also a statement in the informed consent that discusses that participation is purely voluntary. If the study subject does not participate there is no penalty or loss of any benefits. A study subject may discontinue from the study at any time for any reason with no penalty of loss of benefits.